Risks of Gastroesophageal Reflux in the Endotracheal Intubation or the I-gel

NCT ID: NCT03634449

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2020-09-13

Brief Summary

In the use of the second supraglottic airway device- i-gel in the laparoscopic pneumoperitoneum and Trendelenburg (LPT) surgical positioning, our data reported that the leak fraction in the i-gel group was higher than in the endotracheal tube group.1 These air leak may be gone into the GI tract and cause the gastric distension resulting in the increasing risk of aspiration. Few studies investigated whether the risk of occurrence of the gastroesophageal reflux (GER), the changes of the lower esophageal sphincter (LES) while the GER occurred, and the stomach fullness in the i-gel group than in the endotracheal tube group.

We aim to observe the changes of gastroesophageal function parameters by esophageal manometry, pH impedance, and intra-abdominal pressure before and after laparoscopic pneumoperitoneum during anesthesia, all via the second SADs.

Detailed Description

Background: In the use of the second supraglottic airway device- i-gel in the laparoscopic pneumoperitoneum and Trendelenburg (LPT) surgical positioning, our data reported that the leak fraction in the i-gel group was higher than in the endotracheal tube group.1 These air leak may be gone into the GI tract and cause the gastric distension resulting in the increasing risk of aspiration. Few studies investigated whether the risk of occurrence of the gastroesophageal reflux (GER), the changes of the lower esophageal sphincter (LES) while the GER occurred, and the stomach fullness in the i-gel group than in the endotracheal tube group. The LES is the important physiological mechanisms that prevent regurgitation and aspiration. The previous study has been investigated that LES would have adaptive response in using the endotracheal tube in the LPT setting. However, the change of LES pressure and gastroesophageal reflux during the LPT surgical settings using the i-gel is still unknown.

The esophageal manometry has pressure sensor to measure the LES pressure. The combined esophageal multichannel intraluminal impedance and pH monitoring (MII -pH) could not only detect the acidic reflux or weakly acidic reflux, but also the height of the regurgitant. We also used the abdominal echo in check the gastric volume before and after the surgery.

Objectives: we aimed to compare the changes of lower esophageal sphincter pressure (LESP) and the occurrence of the GER during the LPT setting by esophageal manometry and MII-pH monitor between the endotracheal tube (ETT) and the i-gel group. The gastric volume before and after surgery has been checked by abdominal echo. We also observed the respiratory parameters changes while the GER occurred.

Patients and methods: Consecutive patients who will receive scheduled laparoscopic surgery under general anesthesia and aged from 20 to 80 years old will be enrolled. All subjects provide basic demographic data. The patients have been randomized into the i-gel or ETT group by sealing envelope. After induction, the MII-pH monitor has been pre-attached to the esophageal manometry. Then they will be inserted into the esophagus. The patients have received the ETT or i-gel. Then the respiratory parameters were collected by the GE S/5 Compact Anesthesia Monitor (GE Healthcare, Helsinki, Finland) with a spirometry tube (GE Healthcare, Helsinki, Finland) and D-lite sensor (GE Healthcare, Helsinki, Finland). The data have been continuous recorded. There were four time point of the LESP measured: (1)T1, after induction (without muscle relaxant) (2)T2, ETT or i-gel intubation (3)T3, after LPT setting (4) T4, off LPT setting.

Expected result: We will compared the difference between the patients receiving the i-gel or ETT group about the (1) the changes of LESP in the above four time point (2) the occurrence of the GER and the relationship between the LES and GER (3) gastric volume before and after surgery.

Conditions

Gastroesophageal Reflux in Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

i-gel

After anesthetic durg given, i-gel, a supraglottic airway devices with a gastric suction channel, will be inserted into the patients' airway.

Group Type: EXPERIMENTAL

i-gel

Intervention Type: DEVICE

i-gel is a supraglottic airway devices with a gastric suction channel.

endotracheal tube

After anesthetic durg given, the endotracheal tube, traditional use for protect airway during the laparoscopic surgery, will be inserted into the patients' airway.

Group Type: ACTIVE_COMPARATOR

endotracheal tube

Intervention Type: DEVICE

Endotracheal intubation is a traditional use for protect airway during the laparoscopic surgery.

Interventions

i-gel

i-gel is a supraglottic airway devices with a gastric suction channel.

Intervention Type: DEVICE

endotracheal tube

Endotracheal intubation is a traditional use for protect airway during the laparoscopic surgery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who will receive scheduled surgery with laparoscopic pneumoperitoneum and Trendelenburg (LPT) setting under general anesthesia
• Aged from 20-80 years old

Exclusion Criteria

• Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
• Patients who have the risk of difficult ventilation or intubation.
• pregnant women
• coagulopathy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chih-Jun Lai

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

0965327939

Facility Contacts

Chih-Jun Lai

Role: primary

littlecherrytw@gmail.com

+886965327939 ext. +886965327939

Other Identifiers

201806063RINB

Identifier Type: -

Identifier Source: org_study_id